At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
BI 425809 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
In Brief
A Phase 1 clinical trial evaluating BI 425809 and fluconazole for Healthy. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionJan 2022
TodayJul 2026
First PostedOct 13, 2021
Enrollment StartOct 19, 2021
Primary CompletionJan 10, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.7 years ago
Interventions
BI 425809drug
Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 1. Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 2.
fluconazoledrug
Fluconazole orally as hard capsules once daily for 13 days (Day -4 up to Day 9) in period 2.